[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100562583":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":25,"locations":35,"responsibleParty":54,"collaborators":58,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":64,"sex":70,"minAge":71,"maxAge":18,"enrollmentInfo":72,"targetDuration":18,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":86,"overallStatus":38,"whyStopped":18,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Karolinska Institutet","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention arm (co-produced intervention package to optimize PMTCT care)","EXPERIMENTAL","Pregnant girls\u002Fyoung women 15-24 years living with HIV (new, previously diagnosed, and transfers) receiving PMTCT services in routine healthcare randomized to the intervention between 01st January and 30th June 2026 and followed up for at least one year to 30th June 2027. While the specific intervention will developed earlier in the project, it may include a package of evidence-based approaches such as peer mentor mothers, male partner involvement, flexible hours for girls\u002Fyoung women and mobile phone reminders. A focal team of 2-3 persons will be trained and engaged to drive the implementation of the interventions at randomized faciltiies. The focal team will orient and engage other staff and stakeholders to deliver the interventions, identify and address gaps, and monitor implementation fidelity and quality using standard operating procedures.",[13],"Behavioral: Co-produced intervention to optimize PMTCT care engagement",{"label":15,"type":16,"description":17,"interventionNames":18},"Control: standard care","NO_INTERVENTION","Pregnant AGYW living with HIV (new, previously diagnosed, and transfers) receiving vertical HIV prevention services in routine healthcare centres acting as control facilities, between 01st January and 30th June 2026 and followed up for at least one year to 30th June 2027. No intervention is administered to this arm; participants will receive a standard of care for PMTCT services per Tanzania national guidelines.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"BEHAVIORAL","Co-produced intervention to optimize PMTCT care engagement","While the specific interventions package will developed earlier in the project, it may include evidence-based approaches such as peer mentor mothers, male partner involvement, flexible hours for girls\u002Fyoung women and mobile phone reminders. Overall, the interventions should be brief and easy to integrate into standard care, aiming to 'nudge' or motivate participants (towards improved engagement, retention, and outcomes) as well as health care providers or community stakeholders to better understand and support girls\u002Fyoung women\\'s specific needs. A focal team of 2-3 persons will be trained and engaged to drive the implementation of the interventions at randomized faciltiies. The focal team will orient and engage other staff and stakeholders to deliver the interventions, identify and address gaps, and monitor implementation fidelity and quality using standard operating procedures.",[9],[26,31],{"name":27,"role":28,"phone":29,"phoneExt":18,"email":30},"Anna E Kågesten, PhD","CONTACT","0046707302287","anna.kagesten@ki.se",{"name":32,"role":28,"phone":33,"phoneExt":18,"email":34},"Goodluck Lyatuu, PhD","255022 2771615","glyatuu@mdh.or.tz",[36,47],{"facility":37,"status":38,"city":39,"state":18,"zip":18,"country":40,"countryCode":18,"cosmosGeoPoint":41,"geoPoint":46,"contacts":18},"Management and Development for Health","RECRUITING","Dar es Salaam","Tanzania",{"type":42,"coordinates":43},"Point",[44,45],39.26951,-6.82349,{"lat":45,"lon":44},{"facility":37,"status":38,"city":48,"state":18,"zip":18,"country":40,"countryCode":18,"cosmosGeoPoint":49,"geoPoint":53,"contacts":18},"Kagera",{"type":42,"coordinates":50},[51,52],30.66889,-4.66,{"lat":52,"lon":51},{"type":55,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","Anna Kågesten","Associate Professor",[59],{"name":60,"class":61},"Management and Development for Health, Tanzania","UNKNOWN","100562583","optimizing-prevention-and-care-for-pregnant-and-postpartum-adolescent-girls-and-young-women-with-hiv-in-tanzania-100562583",false,"NCT06605053","Optimizing Prevention and Care for Pregnant and Postpartum Adolescent Girls and Young Women With HIV in Tanzania","ENding HIV Transmission to Infants by Generating Evidence to Optimize Prevention and Care for Pregnant and Postpartum Adolescent Girls and Young Women With HIV in Tanzania (ENGAGE)","ENGAGE","Sub-study 1 (registry-based cohort analysis):\n\nInclusion Criteria:\n\n* Pregnant\u002Fpostpartum adolescent girls and young women (AGYW) with HIV aged 15-24 years, who started PMTCT services between January 1, 2018, and December 31, 2020.\n* Infants born to the included AGYW during this period.\n\nExclusion Criteria:\n\n* AGYW whose ART (Antiretroviral Therapy) status was not recorded.\n* Women who had not started ART.\n\nSub-study 2 (qualitative):\n\nInclusion Criteria:\n\n* AGYW living with HIV who are currently pregnant, previously pregnant\u002Fpostpartum, and never pregnant).\n* HCPs (Health Care Providers) at clinics providing PMTCT services.\n* Spouses\u002Fpartners\u002Fparents of AGYW and community stakeholders within the study setting.\n\nExclusion criteria\n\n\\- Mentally or severely ill individuals unable to participate in the study activities.\n\nSub-study 3 (co-production)\n\nInclusion criteria:\n\n* AGYW, HCPs, spouses\u002Fpartners, parents, and community stakeholders who participated in the qualitative study II.\n* Research team members.\n\nExclusion criteria:\n\n\\- Mentally or severely ill individuals unable to participate in the study activities.\n\nSub-study 4 (cluster-randomized implementation trial)\n\nInclusion criteria:\n\n\\- Pregnant AGYW living with HIV (new, previously diagnosed, and transfers) receiving vertical HIV prevention services in routine healthcare between January 1, 2026, and June 30, 2026, and followed up for at least one year until June 30, 2027.\n\nExclusion criteria:\n\n* AGYW whose ART (Antiretroviral Therapy) status was not recorded.","FEMALE","15 Years",{"count":73,"type":74},222,"ESTIMATED","INTERVENTIONAL",[77],"NA","The goal of this clinical trial is to find better ways to care for pregnant and postpartum adolescent girls and young women (AGYW) aged 15-24 years with HIV in Tanzania, and to prevent them from passing HIV to their babies. The main questions it aims to answer are:\n\n* How often do young pregnant women with HIV go to their health appointments and stay on their treatment up to two years after giving birth?\n* How many babies born to young women with HIV stay HIV-free for two years?\n* How soon do young women with HIV get pregnant again after giving birth, and what factors affect this?\n* What are the best ways to help young women with HIV stay in care and stay healthy during and after pregnancy?\n* What social and structural factors affect whether young pregnant women with HIV go to their health appointments and stay on their treatment?\n* How can we work with young women with HIV to create and test a package of interventions to improve their healthcare during and after pregnancy?\n* Can this package of interventions help young women with HIV stay in care and remain healthy during and after pregnancy?\n\nParticipants will:\n\n* Have their health data analyzed via health service records of all women who received HIV prevention services between 2018 and 2020, and were followed until 2023, across 559 health facilities in Tanzania.\n* Participate in qualitative interviews to share their experiences and challenges with staying in care.\n* Help to co-create a package of interventions to improve care.\n* Take part in a cluster-randomized trial to test these interventions. Researchers will compare the outcomes of the intervention package to see if they improve care engagement, retention, and health outcomes for AGYW with HIV during and after pregnancy.",[80,81,82,83,84,85],"HIV Antiretroviral Therapy (ART) Adherence","PMTCT","Pregnancy","Retention in Care","HIV Viremia","Early Infant HIV Diagnosis",[87,88,89,81,90,91,92,40,93,94],"Adolescent girls and young women","HIV","Vertical transmission","Co-production","Co-design","Intervention","Sub-Saharan Africa","Retention in care","2025-06-27",{"date":97,"type":98},"2025-06-29","ACTUAL",{"date":100,"type":98},"2024-10-07",{"date":102,"type":74},"2027-12",{"name":5,"class":6},2]